LifePearl-Iri Pharmacokinetic Study

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

April 28, 2017

Study Completion Date

September 19, 2017

Conditions
Metastatic Colorectal CancermCRC
Interventions
DEVICE

TACE with irinotecan loaded LifePearl

Arterial embolization will be performed through lobar infusion and using a microcatheter. LifePearl microspheres of 200 µm will be used as preferred beads. They will be loaded with the appropriate dose of irinotecan hydrochloride injectable solution, mixed with the contrast media and distributed to the targeted lobe. The targeted dose is 100 mg of irinotecan per lobe treated, meaning that when treated unilobarly at baseline the total dose received will be 100 mg ( all in one lobe) and in during bilobar treatment, 200 mg in both lobes.

Trial Locations (3)

Unknown

KUL, Leuven

SLK-Kliniken Heilbronn GmbH, Heilbronn

Klinikum Bogenhausen, Städt. Klinikum München GmbH, Munich

All Listed Sponsors
collaborator

Federation Francophone de Cancerologie Digestive

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

lead

Terumo Europe N.V.

INDUSTRY

NCT02547480 - LifePearl-Iri Pharmacokinetic Study | Biotech Hunter | Biotech Hunter